Director, Quality Assurance (176-178) Salient Surgical Technologies, Inc.

Tracking Code
176-178

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES



Maintains all QA files including all quality records, design history files and external standards assuring that the information is current and accurate.
As the Management Representative, manages, schedules and reports on performance of the quality management system to executive management.
As the Management Representative, coordinates and schedules the annual ISO audit with the appropriate Notified Body.
Manages the electronic Document and Data Control system
Monitors compliance of CAPA, MRB, Internal Audits, Supplier Audits and Complaint Handling.
Coordinates and manages Internal and External Audit functions, including any associated corrective actions.
Manages employee training compliance and recordkeeping in accordance with SST quality assurance standards.
Assists with all SST product lot releases and maintains all lot release documentation
Assures that the test plans for inspection and test of products are current and accurate

Required Skills

Knowledge of medical device document control principles, practices, and methods.
Familiar with ISO13485, FDA, MDD and CMDR requirements
Skill in operating the listed tools and equipment.
Ability to communicate effectively, orally and in writing, with employees and governmental agency representatives. Ability to compile status reports.

Required Experience

Bachelors degree
Five years medical device quality assurance experience; or
Any equivalent combination of education and experience.

Location:	Portsmouth, NH United States